FDA WARNING_LETTER - Aqualex Co., Ltd. - October 20, 2023

On June 12, 2024, the FDA issued a Warning Letter to Aqualex Co., Ltd. following an inspection from October 16-20, 2023, citing significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The product "DBH Beverly Hills, EGF FGF DNA, UV Shield" was also identified as an unapproved new drug and misbranded.

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))**: The firm lacked data to validate manufacturing processes and qualify equipment for OTC SPF sunscreen. Their response was inadequate, failing to assess the impact on distributed products or provide detailed plans. 2. **Failure to use appropriately designed equipment (21 CFR 211.63)**: The firm's water system for drug product formulation had stagnant water points (dead-legs), fostering biofilm development. The response was inadequate, not demonstrating proper design, control, or maintenance. 3. **Quality control unit failure (21 CFR 211.22)**: The Quality Unit failed to ensure adequate control over CGMP records, with unauthorized changes possible and original records found marked for shredding. Laboratory data was routinely recorded on temporary records and discarded. The firm's response lacked sufficient detail on record management and impact assessment.